Respiratory Syncytial Virus
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) symptoms.
Detailed description
Rilematovir is an investigational RSV specific fusion inhibitor currently in development for the treatment of RSV infection in both adult and pediatric populations. The study will include a Screening period (Day -1 to Day 1), a Treatment period (Day 1 to Day 7/8 \[depending on timing of first dose\]), and a Follow-up period (Day 8/9 to Day 35). The total study duration of the study for each participant will be up to 35 days. The study will evaluate efficacy and safety of RSV in adult outpatients (18-85 years) who are at high risk of RSV related disease progression and have at least moderate RSV disease. The efficacy assessments include evaluation with electronic patient-reported outcome (ePRO) and the safety assessments include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events.
Interventions
DRUGRilematovir
Rilematovir 250 mg will be administered orally.
DRUGPlacebo
Placebo matching to rilematovir will be administered orally.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Presented to the healthcare facility with symptoms suggestive of a diagnosis of acute respiratory syncytial virus (RSV) infection * Has at least 2 symptoms of lower respiratory tract disease (LRTD), one of which must be scored as at least 'moderate' if the symptoms did not pre-exist before RSV onset, or one of which is scored worse than usual if the symptoms pre-existed * Tested positive for RSV infection using a molecular-based diagnostic assay (polymerase chain reaction \[PCR\] or other) on a bilateral nasal mid-turbinate swab sample * Has at least one of the following high-risk conditions that predispose them to RSV-related disease progression: a. age greater than or equal to (\>=) 65 years, b. congestive heart failure (CHF), c. chronic obstructive pulmonary disease (COPD), d. asthma * Randomized to study intervention treatment within 72 hours after onset of any of the RSV symptoms or worsening of pre-existing symptoms * Not be hospitalized during screening (emergency room or hospital observation status for an anticipated duration of less than \[\<\] 24 hours are not considered as hospitalization)
Exclusion criteria
* Known allergies, hypersensitivity, or intolerance to rilematovir or to any of the excipients of rilematovir or placebo formulation * Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia * Participant has known or suspected (from medical history or participant examination) chronic or acute hepatitis B or C infection * Immunocompromised conditions * Living in institutional care or assisted living facility and also receiving acute care management for any respiratory condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline | Baseline | RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at baseline were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. |
| Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 3 | Day 3 | RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 3 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported. |
| Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 8 | Day 8 | RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 8 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported. |
| Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 14 | Day 14 | RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 14 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported. |
| Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 21 | Day 21 | RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 21 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported. |
| Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 28 | Day 28 | RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 28 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported. |
| Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 35 | Day 35 | RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 35 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings | Up to Day 35 | Abnormal vital parameters included pulse rate: abnormally low \<=45 bpm, abnormally high \>=120 bpm; Systolic Blood Pressure (SBP): abnormally low \<=90 millimeter of mercury (mmHg), Grade 1 (mild): \>140 mmHg to \<160 mmHg, Grade 2 (moderate): \>=160 mmHg to \<180 mmHg, Grade 3 (severe): \>=180 mmHg; Diastolic BP: abnormally low \<=50 mmHg, Grade 1: \>90 mmHg to \<100 mmHg, Grade 2: \>=100 mmHg to \<110 mmHg, Grade 3: \>=110 mmHg; Respiratory rate: Grade 1 (mild): 17-20 breaths per minute, Grade 2 (moderate): 21-25 breaths per minute, Grade 3 (severe): \>25 breaths per minute, Grade 4 (potentially life threatening): intubation; Oxygen saturation: abnormally low: \<95%; Temperature: abnormally high \>38.0 degree celsius. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration. |
| Percentage of Participants With Post-Baseline RSV-related Complications | Up to Day 35 | RSV-related complications were reported. The RSV-related complications included pulmonary complications (primary viral pneumonia, bronchitis, respiratory failure, secondary bacterial pneumonia, and exacerbations of underlying chronic pulmonary diseases \[such as COPD and asthma\]) and extrapulmonary complications (cardiovascular and cerebrovascular disease events, congestive heart failure \[CHF\] or exacerbation of underlying CHF, acute exacerbation of chronic kidney disease, severe dehydration, decompensation of previously controlled diabetes mellitus, and other airway infections). Complications after first intake of study drug were considered for this outcome measure. |
| Plasma Concentration of Rilematovir | Day 1: 1 hour post dose, Day 3: pre-dose and 1 hour post dose, and Follow-up: Day 8 | Plasma concentration of rilematovir was reported. This outcome measure was planned to be analyzed for specified arm only. In this outcome measure, only those timepoints for which individual participants had data were reported. |
| RSV Viral Load Over Time | Baseline, Days 3, 5, 8, 15, and 21 | RSV viral load (subtype: RSV A and RSV B) was measured over time by quantitative reverse transcription polymerase chain reaction (qRT-PCR) in the nasal swab specimens collected at the clinic visits and at home. In this outcome measure, only those timepoints and RSV subtypes (A or B) for which individual participants had data were reported. |
| Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation | Up to Day 35 | New antibiotic use, or new use or increased dose of systemic or inhaled corticosteroids and bronchodilators, or home oxygen supplementation were reported. |
| Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection | Up to Day 35 | Unscheduled outpatient clinic visits, emergency room visits or hospitalization for respiratory infection were reported. |
| Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance | Up to Day 35 | Percentage of participants meeting a composite endpoint of either developing RSV-related complications (pulmonary and extra-pulmonary) and/or needing RSV-related medical attendance was derived. |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Day 35 | An adverse events (AEs) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE which occurred at or after the initial administration of study intervention through the end of the study (that is, Day 35) was considered treatment-emergent. |
| Percentage of Participants With Treatment-emergent Abnormal Clinical Laboratory Findings | Up to Day 35 | Abnormal clinical laboratory findings were reported. Laboratory abnormalities were determined as per division of microbiology and infectious diseases(DMID) toxicity as Grade 1:mild(transient or mild discomfort \[less than {\<} 48 hours\]; no medical intervention/therapy required); Grade 2:moderate (mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required); Grade 3:severe (severe marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible); Grade 4:life-threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable). Only Grade 2 abnormalities are reported in this outcome measure. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration. |
| Percentage of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) | Up to Day 35 | Various ECG variables assessed were heart rate: abnormally low (less than or equal to \[\<=\] 45 beats per minute \[bpm\]), abnormally high (greater than or equal to \[\>=\] 120 bpm); PR interval: abnormally high (\>=210 milliseconds \[msec\]); QRS interval: abnormally high (\>=120 msec); QTc: borderline prolonged: \>450 msec and \<=480 msec, prolonged: \>480 msec and \<=500 msec, pathologicaly prolonged: \>500 msec. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration. |
Countries
Argentina, Bulgaria, Canada, Germany, Hungary, Italy, Japan, Poland, South Africa, Spain, Sweden, Thailand, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participant received oral dose of placebo matching to rilematovir twice daily for 7 days. | 1 |
| Rilematovir 250 mg Bid Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days. | 4 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | Rilematovir 250 mg Bid |
|---|---|---|---|
| Age, Continuous | 55 years | 52.4 years STANDARD_DEVIATION 19.88 | 51.8 years STANDARD_DEVIATION 22.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 5 Participants | 4 Participants |
| Region of Enrollment BULGARIA | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment HUNGARY | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment POLAND | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment UNITED STATES | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 4 |
| other Total, other adverse events | 0 / 1 | 0 / 4 |
| serious Total, serious adverse events | 0 / 1 | 0 / 4 |
Outcome results
Primary
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at baseline were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores.
Time frame: Baseline
Population: Intent-to-Treat infected (ITT-i) analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection (positive test by central laboratory analysis) were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline | Participants 5 | 2.25 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline | Participant 1 | 1.25 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline | Participant 2 | 1.25 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline | Participant 3 | 1.25 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline | Participant 4 | 2.25 Scores on a scale |
Primary
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 14
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 14 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.
Time frame: Day 14
Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 14 | Participant 5 | 0 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 14 | Participant 1 | 1.25 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 14 | Participant 2 | 1 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 14 | Participant 3 | 0 Scores on a scale |
Primary
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 21
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 21 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.
Time frame: Day 21
Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 21 | Participant 5 | 0 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 21 | Participant 1 | 0 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 21 | Participant 2 | 1 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 21 | Participant 3 | 0 Scores on a scale |
Primary
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 28
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 28 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.
Time frame: Day 28
Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 28 | Participant 5 | 0 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 28 | Participant 1 | 0.5 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 28 | Participant 2 | 0.75 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 28 | Participant 3 | 0 Scores on a scale |
Primary
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 3
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 3 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.
Time frame: Day 3
Population: ITT-I analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 3 | Participant 5 | 1.75 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 3 | Participant 3 | 0.75 Scores on a scale |
Primary
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 35
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 35 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.
Time frame: Day 35
Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 35 | Participant 5 | 0 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 35 | Participant 1 | 0 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 35 | Participant 2 | 0 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 35 | Participant 3 | 0 Scores on a scale |
Primary
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 8
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 8 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.
Time frame: Day 8
Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 8 | Participant 5 | 0.5 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 8 | Participant 1 | 1.25 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 8 | Participant 2 | 1.25 Scores on a scale |
| Rilematovir 250 mg Bid | Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 8 | Participant 3 | 0.75 Scores on a scale |
Secondary
Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance
Percentage of participants meeting a composite endpoint of either developing RSV-related complications (pulmonary and extra-pulmonary) and/or needing RSV-related medical attendance was derived.
Time frame: Up to Day 35
Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance | 0 Percentage of participants |
| Rilematovir 250 mg Bid | Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance | 25.0 Percentage of participants |
Secondary
Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation
New antibiotic use, or new use or increased dose of systemic or inhaled corticosteroids and bronchodilators, or home oxygen supplementation were reported.
Time frame: Up to Day 35
Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation | New antibiotic use | 0 Percentage of participants |
| Placebo | Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation | New use or increased dose of systematic or inhaled corticosteroids and bronchodilators | 0 Percentage of participants |
| Placebo | Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation | Home oxygen supplementation | 0 Percentage of participants |
| Rilematovir 250 mg Bid | Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation | New antibiotic use | 25.0 Percentage of participants |
| Rilematovir 250 mg Bid | Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation | New use or increased dose of systematic or inhaled corticosteroids and bronchodilators | 25.0 Percentage of participants |
| Rilematovir 250 mg Bid | Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation | Home oxygen supplementation | 0 Percentage of participants |
Secondary
Percentage of Participants With Post-Baseline RSV-related Complications
RSV-related complications were reported. The RSV-related complications included pulmonary complications (primary viral pneumonia, bronchitis, respiratory failure, secondary bacterial pneumonia, and exacerbations of underlying chronic pulmonary diseases \[such as COPD and asthma\]) and extrapulmonary complications (cardiovascular and cerebrovascular disease events, congestive heart failure \[CHF\] or exacerbation of underlying CHF, acute exacerbation of chronic kidney disease, severe dehydration, decompensation of previously controlled diabetes mellitus, and other airway infections). Complications after first intake of study drug were considered for this outcome measure.
Time frame: Up to Day 35
Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Post-Baseline RSV-related Complications | 0 Percentage of participants |
| Rilematovir 250 mg Bid | Percentage of Participants With Post-Baseline RSV-related Complications | 0 Percentage of participants |
Secondary
Percentage of Participants With Treatment-emergent Abnormal Clinical Laboratory Findings
Abnormal clinical laboratory findings were reported. Laboratory abnormalities were determined as per division of microbiology and infectious diseases(DMID) toxicity as Grade 1:mild(transient or mild discomfort \[less than {\<} 48 hours\]; no medical intervention/therapy required); Grade 2:moderate (mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required); Grade 3:severe (severe marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible); Grade 4:life-threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable). Only Grade 2 abnormalities are reported in this outcome measure. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration.
Time frame: Up to Day 35
Population: Safety analysis set included all participants who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Treatment-emergent Abnormal Clinical Laboratory Findings | Decrease in hemoglobin (Grade 2) | 0 Percentage of participants |
| Placebo | Percentage of Participants With Treatment-emergent Abnormal Clinical Laboratory Findings | Increase in glucose (Grade 2) | 0 Percentage of participants |
| Rilematovir 250 mg Bid | Percentage of Participants With Treatment-emergent Abnormal Clinical Laboratory Findings | Decrease in hemoglobin (Grade 2) | 25 Percentage of participants |
| Rilematovir 250 mg Bid | Percentage of Participants With Treatment-emergent Abnormal Clinical Laboratory Findings | Increase in glucose (Grade 2) | 25 Percentage of participants |
Secondary
Percentage of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs)
Various ECG variables assessed were heart rate: abnormally low (less than or equal to \[\<=\] 45 beats per minute \[bpm\]), abnormally high (greater than or equal to \[\>=\] 120 bpm); PR interval: abnormally high (\>=210 milliseconds \[msec\]); QRS interval: abnormally high (\>=120 msec); QTc: borderline prolonged: \>450 msec and \<=480 msec, prolonged: \>480 msec and \<=500 msec, pathologicaly prolonged: \>500 msec. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration.
Time frame: Up to Day 35
Population: Safety analysis set included all participants who took at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) | 0 Percentage of participants |
| Rilematovir 250 mg Bid | Percentage of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) | 0 Percentage of participants |
Secondary
Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings
Abnormal vital parameters included pulse rate: abnormally low \<=45 bpm, abnormally high \>=120 bpm; Systolic Blood Pressure (SBP): abnormally low \<=90 millimeter of mercury (mmHg), Grade 1 (mild): \>140 mmHg to \<160 mmHg, Grade 2 (moderate): \>=160 mmHg to \<180 mmHg, Grade 3 (severe): \>=180 mmHg; Diastolic BP: abnormally low \<=50 mmHg, Grade 1: \>90 mmHg to \<100 mmHg, Grade 2: \>=100 mmHg to \<110 mmHg, Grade 3: \>=110 mmHg; Respiratory rate: Grade 1 (mild): 17-20 breaths per minute, Grade 2 (moderate): 21-25 breaths per minute, Grade 3 (severe): \>25 breaths per minute, Grade 4 (potentially life threatening): intubation; Oxygen saturation: abnormally low: \<95%; Temperature: abnormally high \>38.0 degree celsius. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration.
Time frame: Up to Day 35
Population: Safety analysis set included all participants who took at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings | 0 Percentage of participants |
| Rilematovir 250 mg Bid | Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings | 0 Percentage of participants |
Secondary
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse events (AEs) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE which occurred at or after the initial administration of study intervention through the end of the study (that is, Day 35) was considered treatment-emergent.
Time frame: Up to Day 35
Population: Safety analysis set included all participants who took at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 0 Percentage of participants |
| Rilematovir 250 mg Bid | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 0 Percentage of participants |
Secondary
Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection
Unscheduled outpatient clinic visits, emergency room visits or hospitalization for respiratory infection were reported.
Time frame: Up to Day 35
Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection | Unscheduled outpatient clinic visits | 0 Percentage of participants |
| Placebo | Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection | Emergency room visits | 0 Percentage of participants |
| Placebo | Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection | Hospitalization for respiratory infection | 0 Percentage of participants |
| Rilematovir 250 mg Bid | Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection | Unscheduled outpatient clinic visits | 25.0 Percentage of participants |
| Rilematovir 250 mg Bid | Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection | Emergency room visits | 0 Percentage of participants |
| Rilematovir 250 mg Bid | Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection | Hospitalization for respiratory infection | 0 Percentage of participants |
Secondary
Plasma Concentration of Rilematovir
Plasma concentration of rilematovir was reported. This outcome measure was planned to be analyzed for specified arm only. In this outcome measure, only those timepoints for which individual participants had data were reported.
Time frame: Day 1: 1 hour post dose, Day 3: pre-dose and 1 hour post dose, and Follow-up: Day 8
Population: Pharmacokinetic (PK) analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Plasma Concentration of Rilematovir | Participant 1: Day 3 (Pre-dose) | 658 Nanograms per milliliter (ng/mL) |
| Placebo | Plasma Concentration of Rilematovir | Participant 1: Day 3 (1 hour post dose) | 682 Nanograms per milliliter (ng/mL) |
| Placebo | Plasma Concentration of Rilematovir | Participant 1: Follow-up-Day 8 | 9.63 Nanograms per milliliter (ng/mL) |
| Placebo | Plasma Concentration of Rilematovir | Participant 2: Day 3 (pre-dose) | 15.9 Nanograms per milliliter (ng/mL) |
| Placebo | Plasma Concentration of Rilematovir | Participant 2: Day 3 (1 hour post dose) | 465 Nanograms per milliliter (ng/mL) |
| Placebo | Plasma Concentration of Rilematovir | Participant 2: Follow-up-Day 8 | 494 Nanograms per milliliter (ng/mL) |
| Placebo | Plasma Concentration of Rilematovir | Participant 3: Day 1 (1 hour post dose) | 257 Nanograms per milliliter (ng/mL) |
| Placebo | Plasma Concentration of Rilematovir | Participant 3: Day 3 (pre-dose) | 2400 Nanograms per milliliter (ng/mL) |
| Placebo | Plasma Concentration of Rilematovir | Participant 3: Day 3 (1 hour post dose) | 2960 Nanograms per milliliter (ng/mL) |
| Placebo | Plasma Concentration of Rilematovir | Participant 3: Follow-up-Day 8 | 3130 Nanograms per milliliter (ng/mL) |
Secondary
RSV Viral Load Over Time
RSV viral load (subtype: RSV A and RSV B) was measured over time by quantitative reverse transcription polymerase chain reaction (qRT-PCR) in the nasal swab specimens collected at the clinic visits and at home. In this outcome measure, only those timepoints and RSV subtypes (A or B) for which individual participants had data were reported.
Time frame: Baseline, Days 3, 5, 8, 15, and 21
Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure and 'n' (number analyzed) represents number of participants evaluable at the specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | RSV Viral Load Over Time | Participant 5: Baseline: RSV A | 7.57 log10 copies per milliliter (mL) |
| Placebo | RSV Viral Load Over Time | Participant 5: Day 3: RSV A | 4.94 log10 copies per milliliter (mL) |
| Placebo | RSV Viral Load Over Time | Participant 5: Day 5: RSV A | 0 log10 copies per milliliter (mL) |
| Placebo | RSV Viral Load Over Time | Participant 5: Day 8: RSV A | 0 log10 copies per milliliter (mL) |
| Placebo | RSV Viral Load Over Time | Participant 5: Day 15: RSV A | 0 log10 copies per milliliter (mL) |
| Placebo | RSV Viral Load Over Time | Participant 5: Day 21: RSV A | 0 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 2: Day 3: RSV B | 6.71 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 2: Day 8: RSV B | 0 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 2: Day 15: RSV B | 0 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 2: Day 21: RSV B | 0 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 3: Baseline: RSV A | 6.5 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 1: Baseline: RSV B | 6.87 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 3: Day 5: RSV A | 3.37 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 3: Day 8: RSV A | 2.9 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 3: Day 15: RSV A | 0 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 3: Day 21: RSV A | 0 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 3: Day 3: RSV A | 6.4 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 1: Day 3: RSV B | 5.84 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 1: Day 8: RSV B | 0 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 1: Day 15: RSV B | 0 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 1: Day 21: RSV B | 0 log10 copies per milliliter (mL) |
| Rilematovir 250 mg Bid | RSV Viral Load Over Time | Participant 2: Baseline: RSV B | 6.17 log10 copies per milliliter (mL) |